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CBC/ConstaVac Blood Conservation System

by Stryker Corp.

510(k) K881350

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881350 Date30 Sep 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
CAC
Device class
Class II
Regulation
21 CFR Part 868.5830
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CBC/ConstaVac Blood Conservation System is an apparatus for autotransfusion, designed to collect and reinfuse a patient's own blood during and after surgical procedures. It is a sterile, single-patient-use, disposable system that operates as a closed apparatus with an internal vacuum mechanism for postoperative blood reinfusion.

The system is supplied as a disposable unit and is intended for single-patient use. It is used in conjunction with a disposal blood bag for wound drainage collected in the reservoir. The device is classified under product code CAC and has received FDA 510(k) clearance with the decision description of 'Substantially Equivalent'.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CBC/ConstaVac Blood Conservation System used for?

    The CBC/ConstaVac Blood Conservation System is an apparatus for autotransfusion designed to collect and reinfuse a patient's own blood during and after surgical procedures, helping conserve blood resources.

  • Is the CBC/ConstaVac Blood Conservation System sterile and single-use?

    Yes, the system is sterile and intended for single-patient use only. It operates as a closed apparatus with an internal vacuum mechanism for postoperative blood reinfusion.

  • How is the CBC/ConstaVac Blood Conservation System supplied?

    The system is supplied as a disposable unit and is used in conjunction with a disposal blood bag for wound drainage collected in the reservoir.

  • What is the regulatory status of the CBC/ConstaVac Blood Conservation System?

    The device has received FDA 510(k) clearance with the decision description of 'Substantially Equivalent' and is classified under product code CAC.